FDA Registration
Active
🇩🇪 Germany
CardioMem CM 3000-12 BT / SEER 12
Reg #: 3004006614
·
FEI: 3004006614
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG
- Registration Number
- 3004006614
- FEI Number
- 3004006614
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- ODERSTRASSE 77
- City
- TELTOW Brandenburg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K063042
Owner / Operator
- Firm Name
- GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG
- Operator Number
- 9052369
- Address
- ODERSTRASSE 77, --
- City
- TELTOW
- State
- DE-NOTA
- Postal Code
- 14513
- Country
- DE
- Correspondent
- Bert Schadow
US Agent
- Business Name
- MDI CONSULTANTS, INC.
- Contact Name
- Alan P. Schwartz
- Address
- 55 NORTHERN BLVD STE 200
- City
- GREAT NECK
- State
- NY
- ZIP
- 11021
- Country
- US
- [email protected]
- Phone
- 516 4829001
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrocardiograph, Ambulatory (Without Analysis) | MWJ | Class 2 | Cardiovascular | No | 2007-11-05 |
Proprietary Names
CardioMem CM 3000-12 BT / SEER 12
CardioMem CM 3000-12 BT
Establishment Types
Manufacture Medical Device